Diagnostic testing helps healthcare providers screen for or monitor specific diseases or conditions. Healthcare workers use diagnostic testing to assess patient health. It also helps them to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct [1].

Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing.

CLIA quality control standards were established in 1988 and apply to any facility that performs even one applicable test on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any diseased or impairment of, or the assessment of the health of, human beings.”[2] Any facility that conducts testing for these purposes is considered to be a laboratory within the scope of CLIA. They must therefore be certified with the CLIA program that corresponds with the complexity of the tests performed.

[1] https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia

[2] https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493